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MISSION 1820MSKRecalls & reported problems

Bard Peripheral Vascular, Inc. · Mission Disposable Core Biopsy Instrument Kit - 18Gx20cm · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
11
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741097072), received between Oct 10, 2018 and Apr 15, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 5 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Nov 8, 2023Open, Classified

    The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.

    Z-0643-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Device-Device Incompatibility5
  • Break3
  • Detachment of Device or Device Component3
  • Failure to Fire1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • No Consequences Or Impact To Patient2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 15, 2026Failure to Fire; Detachment of Device or Device Component

    ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING A MISSION BIOPSY KIT. PRIOR TO THE PROCEDURE, THE OUTER CANNULA COULDN'T BE FIRED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24884821 ↗
  • InjuryMar 5, 2026Break

    ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING MISSION KIT. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE ALLEGEDLY BROKE IN THE LESION. FURTHER IT WAS REPORTED THAT THE BROKEN NEEDLE REQUIRED REMOVAL IN IR. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 24516415 ↗
  • MalfunctionAug 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION. PRIOR THE PROCEDURE, THE DEVICE PLASTIC TIP WAS BROKEN. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22685396 ↗
  • MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PLASTIC HUB OF THE INNER STYLET ALLEGEDLY FELL OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21069439 ↗
  • MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18333634 ↗
  • MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18333633 ↗
  • MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18333632 ↗
  • MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18333630 ↗
  • MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18333628 ↗
  • MalfunctionOct 10, 2018Break; Break

    IT WAS REPORTED THAT DURING A BIOPSY, THE STYLET NEEDLE ALLEGEDLY FRACTURED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7953924 ↗
  • MalfunctionOct 10, 2018Break; Break

    IT WAS REPORTED THAT DURING A BIOPSY, THE STYLET NEEDLE ALLEGEDLY FRACTURED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE FRACTURED NEEDLE REMAINED INSIDE THE PATIENT AS THE HEALTHCARE PROFESSIONAL WAS UNABLE TO RETRIEVE IT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7953583 ↗

Other INSTRUMENT, BIOPSY devices

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Sources and updates

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